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Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00109421
First received: April 27, 2005
Last updated: February 27, 2017
Last verified: February 2016
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Purpose
The Project ÒRÉ intervention is a half-day community-based HIV/STI intervention program for friendship groups of adolescents that is tailored to African American culture. The four participating community sites will be assigned to either the Project ÒRÉ intervention or a standard health promotion program. Sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. All participants will complete questionnaires before and immediately following the programs and another one 3 months later. Immediately following the program some of the Project ÒRÉ groups will also participate in a focus group to provide feedback about the program.
| Condition | Intervention |
|---|---|
| Sexual Behavior Sexually Transmitted Diseases HIV Infections | Behavioral: Project ÒRÉ |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Prevention |
| Official Title: | PROJECT ÒRÉ: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Conduct elicitation research in the study community [ Time Frame: 18 Months ]To conduct elicitation research in the study community to: assess the applicability of the existing Project ÒRÉ intervention modules, modify the intervention for the specific populations that are targeted in the current study, and incorporate local data in the production of three brief videos involving youth in the study community
Secondary Outcome Measures:
- Test the efficacy of the intervention [ Time Frame: 18 Months ]To use a group-randomized controlled design to conduct a test of the efficacy of the Project ÒRÉ intervention.
- Conduct a qualitative process evaluation [ Time Frame: 18 Months ]To conduct a qualitative process evaluation to assess the acceptability of the experimental intervention in a new community using a subset of the participants in the experimental condition.
| Enrollment: | 420 |
| Study Start Date: | November 2004 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental arm
In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. A subset of groups will participate in a process evaluation focus group immediately following the program.
|
Behavioral: Project ÒRÉ
Community-based adolescent social network HIV/STI intervention tailored to African American culture
Other Name: ÒRÉ
|
|
No Intervention: Attention control group
The attention control group will receive a standard health promotion control program which has been used previously with similar populations. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires.
|
Detailed Description:
A group-randomized controlled design to test the efficacy of the Project ÒRÉ intervention, a community-based adolescent social network HIV/STI intervention tailored to African American culture. Four community based organization sites (CBOs) will be randomly assigned to an experimental or attention control condition. In both conditions, sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. The attention control group will receive a standard health promotion control program which has been used previously with similar populations. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. In the experimental condition, a subset of groups will participate in a process evaluation focus group immediately following the program.
Eligibility| Ages Eligible for Study: | 14 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Female
- Between the ages of 14-18
- Self-identifies as African American
- Sexually experienced
- Willing to participate in a single five-hour workshop and a one-hour follow-up session
- Willing to nominate 2-5 close female friends ages 14-21 to participate in the study with her
- Lives in the experimental intervention community
- Ability to obtain permission from parent or legal guardian and assent from minors or consent from those above age of majority
Exclusion Criteria:
- Individual reports predominantly same gender sexual behavior
- Recent homelessness
- Visibly distraught or unstable (i.e. suicidal, manic, exhibiting violent behavior, etc.)
- Intoxicated or under the influence of psychoactive agents
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109421
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109421
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
| Principal Investigator: | M. Margaret Dolcini, Ph.D. | University of California, San Francisco |
More Information
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00109421 History of Changes |
| Other Study ID Numbers: |
ATN 034 |
| Study First Received: | April 27, 2005 |
| Last Updated: | February 27, 2017 |
Keywords provided by University of North Carolina, Chapel Hill:
|
adolescent female community-based |
social network HIV/STI intervention High HIV-risk African American adolescent females |
Additional relevant MeSH terms:
|
Infection HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on July 21, 2017